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NCT02604485 · ClinicalTrials.gov registry record · Phase 2
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
A Phase 2 study, sponsored by Xoma (US).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02604485: Completed Phase 2 study, sponsored by Xoma (US).
NCT02604485 is a Phase 2 study that has completed, run by Xoma (US). The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02604485, a Phase 2 study, has completed, sponsored by Xoma (US).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
Primary Outcome
Safety assessed by treatment-emergent adverse events
Interventions
- DRUG Cohort 4
- DRUG Cohort 3
- DRUG Cohort 2
- DRUG Cohort 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT02604485 record still lists
NCT02604485 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Cohort 4 is the first listed.
NCT02604485 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02604485 about?
NCT02604485 is a clinical study titled "A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism". The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
What is the current status of trial NCT02604485?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-10. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02604485?
The interventions under investigation include: Cohort 4 (DRUG), Cohort 3 (DRUG), Cohort 2 (DRUG), Cohort 1 (DRUG).
Who is sponsoring clinical trial NCT02604485?
This trial is sponsored by Xoma (US), which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02604485's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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